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Specific IgG Antibody in Patients With Primary Antibody Deficiencies Treated With Subcutaneous Immunoglobulin

NCT00661401 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2008-04-18

No results posted yet for this study

Summary

Objective: Measure serum IgG antibody to Streptococcus pneumoniae serotypes 1, 3, 5, 6B, 9V e 14, Haemophilus influenzae type b and tetanus toxoid in patients with primary antibody deficiencies who were treated with subcutaneous immunoglobulin infusions.

Conditions

  • Common Variable Immunodeficiency
  • Agammaglobulinemia

Interventions

BIOLOGICAL

gammaglobulin

They were administered a polyvalent, pasteurized liquid immune globulin subcutaneously (human 16% Beriglobin ®, Germany) with doses ranging from 57 to 132 mg/kg/week in order to maintain the same dosage they received by intravenous route monthly previous to this protocol. After a wash-out period (15 weeks) of the subcutaneous immunoglobulin administration, blood was collected every 4 weeks immediately before infusions. The infusions were administered using battery-powered ambulatory syringe drivers together with 10 or 20 ml syringe and infusions sets according to a pre-defined protocol (Gardulf et al, 2006).

Sponsors & Collaborators

  • CSL Behring

    collaborator INDUSTRY

  • Federal University of São Paulo

    lead OTHER

Principal Investigators

  • Beatriz T Costa Carvalho, md PhD · Federal University of São Paulo

  • Charles K Naspitz, md MSc · Federal University of São Paulo

  • Albertina RB Pizzamiglio, md MSc · Federal University of São Paulo

  • Aparecida T Nagao-Dias · Federal University of Ceará

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-01-31
Primary Completion
2002-11-30
Completion
2002-11-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00661401 on ClinicalTrials.gov